Misc. Drugs

Two articles popped up in my inbox today. The first tells the sad story of a man who died after taking a supplement known as “Stiff Nights.”

“A Kansas City man died last year after taking an unapproved erectile dysfunction drug allegedly labeled as a dietary supplement, a Jackson County lawsuit says.

David R. McElwee, 39, suffered a loss of blood pressure, which ultimately led to a fatal heart attack, after taking a product sold under the brand name Stiff Nights, according to the lawsuit filed in August on behalf of his children.

The second is an exposé on the supplement market in today’s issue of USA Today:

Far from an isolated case, a USA TODAY investigation finds that a wide array of dietary supplement companies caught with drug-spiked products are run by people with criminal backgrounds and regulatory run-ins. Consumers buying products from these firms are in some cases entrusting their health and safety to people with rap sheets for crimes involving barbiturates, crack cocaine, Ecstacy and other narcotics, as well as arrests for selling or possessing steroids and human growth hormone. Other supplement company executives have records of fraud, theft, assault, weapons offenses, money laundering or other offenses, the investigation shows.

A recent international online pharmacy crackdown has led to over $41 million in illegal drugs confiscated. These counterfeit drugs were part of a wave of over 1,600 websites that were shut down during the series of busts conducted by U.S. and international regulators. The U.S. Food and Drug Administration (FDA) claimed that it used federal court warrants to seize website domain names and leave internet messages for visitors, informing them of the consequences of selling counterfeit drugs.

Medicine that is not approved by the FDA or prescribed by your doctor can have minor variations in ingredients, drastically affecting the possible outcomes from their use. Often, these variations can lead to a worsening of illness, a development of a resistance to the correct medicines that would have aided in recovery, or even alter how other medicines affect your body.

In addition to the health risks faced by using drugs from illegitimate online pharmacies, one further risks fraud when doing business with such companies — if a company is comfortable providing fake drugs, what is to say such a company wouldn’t steal your personal or financial information as well.

Published in a 2005 edition of the Journal of the American Medical Association, a study by Dr. Eydie L. Moses-Kolko et al., titled “Neonatal Signs After Late In Utero Exposure to Serotonin Reuptake Inhibitors,” reviews the danger posed to infants whose mothers used serotonin reuptake inhibitors (SRIs), a new type of antidepressant and anti-anxiety medication.

Reviewing previously-published medical literature regarding neonatal outcomes after late in-utero exposure to SSRI drugs, the Moses-Kolko et al. team found that “compared with early gestational SRI exposure or no exposure, late SRI exposure carries an overall risk ratio of 3.0 … for neonatal behavioral syndrome.”[1] That is, infants whose mothers used selective serotonin reuptake inhibitors or selective norepinephrine reuptake inhibitors late in pregnancy were three times as likely to be born with neonatal behavioral syndrome as were children whose mothers only used these drugs in early pregnancy or refrained entirely.

Sixty-one percent of the cases of neonatal behavioral syndrome were related to Paxil® exposure, and twenty-two percent of the cases of neonatal behavioral syndrome were found to be caused by Prozac® exposure; other cases of neonatal behavioral syndrome were caused by other SSRIs.[3]

This Moses-Kolko piece also reviewed the findings of other contemporary research on the dangers of SSRI use in pregnancy. Some of the findings cited associate SSRI use with “major congenital anomalies,”[4] “poor neonatal adaptation,”[5] “prematurity,”[6] “respiratory difficulties,”[7] and “low birth weight.”[8] Other birth defects associated with SSRI use during pregnancy can be found here.

Because the manufacturers of Paxil®, Prozac®, and other SSRIs do not include specific, overt warnings for users regarding the increased risk of birth defects, many SSRI lawsuits are currently being filed. If you used Paxil® or Prozac® during pregnancy and your child was born with neonatal behavioral syndrome or another congenital malformation, please do not hesitate to contact our team of Paxil® birth defect lawyers and Prozac® birth defect lawyers.

When you are ready, you may call or e-mail for a free, no obligation case consultation at (855) 452-5529 or justinian@dangerousdrugs.us. We have the skills, resources, and experience required to win the justice you and your loved ones deserve.

A 2006 study from Denmark, published in the medical journal Epidemiology,has evaluated the risk for birth defects and other neonatal complications that results from maternal use of SSRI drugs during pregnancy. “SSRI” stands for selective serotonin reuptake inhibitor and represents a new class of antidepressant drugs that change levels of serotonin in the brain. Serotonin plays an important role in mood, appetite, and sleep regulation, but it has also recently been found that serotonin plays an important role in fetal development. In the last ten to fifteen years, a great deal of research has come out linking maternal SSRI use in pregnancy and birth defects, and this study from Denmark aimed to further evaluate that risk.

In their paper titled “Maternal Use of Selective Serotonin Reuptake Inhibitors and Risk of Congenital Malformation,” the Wogelius et al team studied 1051 women who used SSRI drugs during the first trimester of pregnancy, 453 who used SSRIs during the remaining trimesters, and compared the health of children born to these women to children born to 150,780 women who did not use SSRIs during pregnancy.

Of the children born to the 150,780 women who did not use SSRIs during pregnancy, 3.4% had children with birth defects, compared with 4.9% of children whose mothers used SSRIs during the first trimester of pregnancy, and 6.8% of children whose mothers used SSRIs during the last two trimesters of pregnancy.[1]

The congenital malformations that were associated with maternal SSRI use during pregnancy ranged in type, but could be grouped generally into three main kinds: 29% cardiovascular, 31% muscle and bone defects, and 14% were defects related to digestive organs.[2]

As this study was a prospective study aimed at evaluating correlations between increased rates of birth defects and maternal SSRI use, it does not provide us with biochemical proof of how SSRIs cause these birth defects. Nonetheless, this study goes great length to demonstrate a strong connection between birth defects and SSRI use during pregnancy, and as such, this article may be used in a SSRI birth defect lawsuit to illustrate to a court that pharmaceutical companies knew, or should have known, of the increased risk for birth defects posed by the use of their products.

If you or a loved one used an SSRI during pregnancy and your child was born with a congenital malformation, you may be entitled to compensation from pharmaceutical companies for undue injury to your child caused by SSRI drugs. At your convenience, you may contact our team of qualified, experienced SSRI birth defect lawyers at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no obligation case consultation.

We have the resources and knowledge required to defend your family against the largest pharmaceutical companies, and we will be with you every step of the way.

Spina Bifida (“myelomeningocele” being the most common form) is a birth defect in the larger class of “neural tube defects,” characterized by the malformation or underdevelopment of the neural tube in a developing infant before birth. In spina bifida, “the backbone and spinal canal do not close before birth”[1] as they normally would.

PubMed Health, a service of the United States National Library of Medicine, states “Normally, during the first month of a pregnancy, the two sides of the spine (or backbone) join together to cover the spinal cord, spinal nerves and meninges (the tissues covering the spinal cord).”[2] In spina bifida, this does not happen, causing “the spinal cord and meninges (the tissues covering the spinal cord) to stick out of the child’s back.”[3]

In the general population, spina bifida “may affect as many as 1 out of every 800 infants,”[4] but several risk factors that increase the chances of a baby being born with spina bifida have recently been established. First, low levels of the vitamin folic acid in pregnant mothers are currently believed to place newborns at risk because of folic acid’s known role in the development of the brain and spinal cord.[5] It is also believed that a virus may play a role in the incidence of spina bifida in newborns “since there is a higher rate of this condition in children born in the early winter months.”[6] It has also recently been discovered that maternal use of selective serotonin reuptake inhibitor (SSRI) antidepressant drugs during pregnancy can dramatically raise the risk of spina bifida in newborns. The main SSRI linked to spina bifida is Celexa®, but use of other SSRI drugs such as Zoloft®, Paxil®, Prozac®, and Lexapro® may also place children at increased risk.

Signs of Spina Bifida

Signs that your child may be born with spina bifida are numerous. Symptoms include “loss of bladder or bowel control,”[7] “partial or complete lack of sensation,”[8] “partial or complete paralysis of the legs,”[9] “weakness of the hips, legs, or feet of a newborn,”[10] “abnormal feet or legs, such as clubfoot,”[11] “build up of fluid inside the skull (hydrocephalus),”[12] “hair at the back part of the pelvis called the sacral area,”[13] and “dimpling of the sacral area.”[14]

Much of the time, a neurologist can test for spina bifida before birth with a blood test known as a “quadruple screen,”[15] which evaluates the newborn’s level of the protein “maternal alpha fetoprotein,”[16] as higher levels of maternal alpha fetoprotein are indicative of (but do not confirm) a spina bifida diagnosis.[17] Confirmation of a spina bifida diagnosis before birth requires either pregnancy ultrasound or aminocentesis.[18]

After birth, a physician may see that a child has spina bifida though a neurologic examination, which “may show that the child has loss of nerve-related functions below the defect. For example, watching how the infant responds to pinpricks at various locations may reveal where he or she can feel the sensations. Tests done on the baby after birth may include x-rays, ultrasound, CT, or MRI of the spinal area.”[19]

Complications of Spina Bifida

Though this list may not be all-inclusive, PubMed Health states that complications of spina bifida can include:

“Difficult delivery with problems resulting from a traumatic birth, including cerebral palsy and decreased oxygen to the brain

A study from Finland published in a 2011 edition of Obstetrics and Gynecology has found a strong link between maternal use of SSRIs during pregnancy and spina bifida. This study, published by Heli Malm, MD, Ph.D. et al. has found that infants born to mothers who used Celexa® during pregnancy were about 2.4 times more likely to be born with neural tube defects such as spina bifida than were children born to mothers who did not use SSRIs during pregnancy.[21]

Treatment for Spina Bifida

Usually, surgery early on in a child’s life is required to correct spina bifida because it is dangerous for the child to have its spinal cord partially exposed, unprotected by the spine. Sadly, “most children will require lifelong treatment for problems that result from damage to the spinal cord and spinal nerves. This includes:

Gentle downward pressure over the bladder may help drain the bladder. In severe cases, drainage tubes, called catheters, may be needed. Bowel training programs and a high fiber diet may improve bowel function.

Orthopedic or physical therapy may be needed to treat musculoskeletal symptoms. Braces may be needed for muscle and joint problems.

Neurological losses are treated according to the type and severity of function loss.

Follow-up examinations generally continue throughout the child’s life. These are done to check the child’s developmental level and to treat any intellectual, neurological, or physical problems.

Visiting nurses, social services, support groups, and local agencies can provide emotional support and assist with the care of a child with a myelomeningocele who has significant problems or limitations.”[22]

We are here to help you

Due to the fact that the manufacturers of Celexa® and other dangerous SSRI drugs do not include anything about birth defects such as spina bifida on their warning labels in the face of clear evidence of their capacity to increase the risk for newborns being born with major birth defects, a number of Celexa® lawsuits and other SSRI birth defect lawsuits are currently being filed. If you used an SSRI during pregnancy, unaware of the risks posed to your developing child, and your child was born with spina bifida or another birth defect, please do not hesitate to contact our law firm at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no-obligation case consultation.

We have the experience, resources, and skills required to go up against even the largest of pharmaceutical companies and win the justice you and your family deserve.

Anal atresia, or “imperforate anus,” is a congenital birth defect “in which the opening to the anus is missing or blocked.”[1] PubMed Health, a prominent online medical encyclopedia curated by the U.S. National Library of Medicine, states that anal atresia may manifest in several different ways:

“The rectum may end in a blind pouch that does not connect with the colon.

The rectum may have openings to the urethra, bladder, base of the penis or scrotum in boys, or vagina in girls.

Signs that your child was born with anal atresia are numerous and clear. Symptoms include “anal opening very near the vagina opening in girls,”[3] the baby failing to defecate within the first 24 to 48 hours of life,[4] “missing or moved opening to the anus,”[5] “stool [passing] out of the vagina, base of penis, scrotum, or urethra”[6].

Treatment for Anal Atresia

MedlinePlus states that when planning treatment for your baby with anal atresia, “the infant should be checked for other problems, especially those affecting the genitals, urinary tract, and spine.

Surgery to correct the defect is needed. If the rectum connects with other organs, these organs will also need to be repaired. A temporary colostomy (connecting the end of the large intestine to the abdomen wall so that stool can be collected in a bag) is often needed.”[7]

Anal Atresia Linked to Maternal SSRI Use

In 2007, medical researcher Carol Louik et al. published research illustrating a clear link between maternal use of SSRIs during pregnancy with the development of a variety of birth defects including anal atresia.[8] SSRIs are a new type of antidepressants such as Prozac®, Paxil®, Zoloft®, Celexa®, and others, that aim to increase the levels of serotonin between brain cells by blocking the “reuptake” of serotonin back into brain cells after a nerve fires.

While serotonin had been known to play a role in mood, appetite, and sleep, it has recently been established by TW Sadler et al that serotonin also plays a role in fetal development. So, when a mother alters her own serotonin levels, and thus alters the levels of serotonin reaching her developing child, developmental complications may ensue.

Specifically, Carol Louik and her team found that maternal use of Prozac® during pregnancy raises the risk of bearing a child with anal atresia by 40%.[9] Maternal use of Celexa® was associated with a three-fold increased risk of anal atresia,[10] and maternal use of Zoloft® was found to raise the risk of anal atresia by a shocking 440%.[11]

Prognosis for Anal Atresia

Thankfully, the outlook for babies with anal atresia is good. Though complications such as constipation may occur,[12] MedlinePlus reassures, writing that “Most defects can successfully be corrected with surgery. Most children with mild defects do very well.”[13]

We are Here to Help

Because the manufactures of Prozac®, Celexa®, and Zoloft®, do not include on their warning labels anything to do with the variety of birth defects for which they raise the risk for development, many SSRI birth defects lawsuits are currently being filed. If you used Zoloft®, Celexa®, or Prozac® during pregnancy and your child was born with anal atresia, you may be entitled to financial compensation for the injuries you and your family have incurred. For a free, no-obligation case consultation, you may contact our law firm at your convenience by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us. We have the experience and resources required to defend the rights of your family.

A recent study published in the British Journal of Medicine has investigated the connection between maternal use of selective serotonin reuptake inhibitor drugs (SSRIs) such as Zoloft®, Paxil®, Prozac®, Celexa®, and Lexapro® during pregnancy and the development of persistent pulmonary hypertension in the newborn. This study, published by Helle Kieler et al. corroborates earlier research that had established the connection between mother use of SSRIs during pregnancy and children being born with persistent pulmonary hypertension, such as that of Christina Chambers et al. (2006) published in the New England Journal of Medicine.

Persistent pulmonary hypertension of the newborn (PPHN) is a congenital (present at birth) heart condition in which the child does not adjust to breathing outside the womb. Before birth, an infant does not use his or her lungs, and blood simply bypasses the lungs. When the child takes his or her first breath though, a change in pressure in the lungs draws blood to the lungs and helps close passageways in the heart used in circulation before birth. In babies with PPHN, however, “these changes may not occur and the baby’s circulation returns back to the fetal system with blood directed away from the lungs.”[1] When blood is not directed to the lungs, it cannot be oxygenated, and thus essentially induces a degree of suffocation in the newborn.

To evaluate whether or not maternal use of SSRI drugs during pregnancy was correlated with this birth defect, the Kieler team undertook a “population based cohort study using data from the national health registers”[2] of Denmark, Finland, Iceland, Norway, and Sweden. Of the 11,014 women found to have used SSRIs after the 20th gestational week,[3] 33 infants were born with PPHN.[4] While this may seem like a small number of cases given the number of women who used SSRIs late in pregnancy, it is not.

Persistent pulmonary hypertension of the newborn is a very rare condition, normally affecting about 12 in 10,000 infants.[5] Kieler’s findings show that when mothers use SSRIs late during pregnancy, the risk for PPHN is doubled. Sadly, it is stated at the conclusion of Kieler’s piece that “Around 15% of infants with persistent pulmonary hypertension of the newborn will die.”[6]

Kieler also evaluated the relative danger of different SSRI drugs and found that while some SSRIs were more dangerous than others, all SSRIs tested significantly raised the risk of bearing children with PPHN:

Fluoxetine (Prozac®) was found to make children 2 times as likely to be born with PPHN.[7]

Citalopram (Celexa®) was found to make children 2.3 times as likely to be born with PPHN.[8]

Paroxetine (Paxil®) was found to make children 2.8 times as likely to be born with PPHN.[9]

Sertraline (Zoloft®) was found to make children 2.3 times as likely to be born with PPHN.[10]

Any steps one can take to lower the chance of inducing birth defects should be taken. If you use SSRIs and have become pregnant, speak with your doctor before stopping SSRI medications, as adverse side-effects may occur.

Due to the fact that none of the labeling of these SSRIs includes any warning regarding PPHN, mothers around the country and across the globe are unknowingly placing their unborn children at risk of serious health conditions, including PPHN and others. Because of this, a number of SSRI lawsuits are currently being filed for injury caused to unborn children by these drugs. If you or a loved one used SSRIs during pregnancy and your child was born with PPHN or another defect, please do not hesitate to contact our law firm for a free consultation.

We can be reached by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us. We have the compassion, resources, and experience required to win the justice you and your family deserve, and we are here to help.

A study published in 2002 in the American Journal of Psychiatry by Dr. Gregory E. Simon, et al. goes great lengths to elucidate the danger of maternal use of antidepressant drugs during pregnancy. In this study, Simon gathered data from the Group Health Corporation, “a prepaid health plan serving approximately 400,000 members in Washington State.”[1]

Reviewing several hundred children born to mothers who used SSRIs during pregnancy and comparing the health of those children to the health of children whose mothers had not used SSRIs during pregnancy, Simon found that the risk of low birth weight for infants whose mothers used SSRIs was more than twice that of newborns in the general population.[2] And, even more shockingly, risk of premature birth for babies born to mothers who had used such antidepressants was more than four times that of babies in the general population.[3]

Simon summarizes the findings of his team, stating “We found an association between SSRI exposure and lower gestational age with a consequent effect on birth weight. For both measures, significant differences were seen in the SSRI group but not in the tricyclic antidepressant group, suggesting a specific effect of SSRI exposure rather than a confounding effect of maternal depression.”[4] If low birth weight and lower gestational age were simply consequences of maternal depression during pregnancy, we would expect that infants born to mother who used tricyclic antidepressants would exhibit the same risk for congenital complication as did infants born to mothers who used SSRIs. This, however, was not the case, and thus SSRIs alone are implicated in playing a causal role in premature birth and low birth weight.

Concluding, Dr. Simon warns that mothers should exercise caution if using any antidepressant drugs during pregnancy, especially SSRIs. Examples of SSRIs associated with birth defects are Paxil®, Prozac®, Zoloft®, Celexa®, and others. Because the risks these drugs pose to developing infants are not included on the warning labels for these drugs, and have thus caused injury to thousands of infants around the world, Zoloft® lawsuits and Paxil® lawsuits (among others) are currently being filed.

If you believe your child was injured by Zoloft® or Paxil® side-effects, please do not hesitate to contact our law firm by phone at (855) 452-5529 or by e-mail at justinian@dangerousdrugs.us for a free, no obligation consultation. Our team of Zoloft® lawyers and Paxil® attorneys have the experience, resources, and skill required to bring even the largest pharmaceutical manufactures to justice and secure the compensation you and your loved ones deserve.

A recent study published in the Archives of General Psychiatry set out to determine whether it was worse for a developing fetus to be exposed to antidepressant drugs during gestation or to be carried to term by a mother-to-be who suffered from depression during pregnancy. This study, published by Dr. Tim F. Oberlander et al. was titled “Neonatal Outcomes After Prenatal Exposure to Selective Serotonin Reuptake Inhibitor Antidepressants and Maternal Depression Using Population-Based Linked Health Data,” and as the title suggests, focused on the effects of a new type of antidepressant drugs, selective serotonin reuptake inhibitors (SSRIs) such as Prozac®, Zoloft®, Paxil®, Celexa®, and others.

Data for the Oberlander study was collected using three groups from the population of British Colombia, Canada: infants born to depressed mothers who used SSRIs during pregnancy, infants born to depressed mothers who did not use SSRIs, and a control group made up of infants born to mothers who did not suffer from depression (and also did not use SSRIs). In all, participants totaled over 100,000 infant-mother pairs.[1]

Results showed that maternal depression alone contributes to low birth weight, but that use of SSRIs exacerbated that risk. Furthermore, it was demonstrated that exposure to SSRIs during gestation fostered an increased risk of neonatal respiratory distress (13.9% vs 7.8%), jaundice (9.4% vs 7.5%), and feeding problems (3.9% vs 2.4%)[2] when compared with babies born to depressed mothers who did not use antidepressant medications.

Because common SSRI warning labels, such as those for Zoloft® or Paxil®, include no information regarding these risks posed the developing fetus, an increasing number of Zoloft® lawsuits and Paxil® lawsuits are currently being filed. If you used Zoloft® or Paxil® during pregnancy and your child was born with these or other birth defects, including a variety of heart malformation defects such as septal defects or persistent pulmonary hypertension of the newborn, please do not hesitate to contact our law firm for a free consultation at (855) 452-5529 or contact me personally by e-mail at justinian@dangerousdrugs.us. We have the experience and resources required to go up against even the largest of pharmaceutical manufacturers and win the compensation you and your family deserve.

In 2010, a Danish study published in the medical journal Clinical Epidemiology set out to evaluate the danger posed to infants born to mothers who used selective serotonin reuptake inhibitors (SSRIs, a new class of antidepressant drugs including Zoloft®, Paxil®, and Prozac®) during early pregnancy.

The study, published by Jette B. Kornum et al. compared the health of 213,712 babies born to mothers who did not use SSRIs during pregnancy to 2,062 women who did use SSRIs during pregnancy, [1] and found that overall, children born to mothers who used SSRIs were more likely to be born “with malformations”[2] (5.1% were born with malformations) than were children born to mother who did not use SSRIs during pregnancy (3.5%).[3]

Concerning cardiac malformations specifically, the Kornum piece established that maternal use of SSRIs during early pregnancy was associated with a 70% increased risk for heart-related birth defects[4] that “could be causal”[5]. This finding has also been corroborated by researchers around the world.

Because drugs such as Zoloft® and Paxil® (among others) do not include warnings about the risk of congenital heart malformation in newborns when expecting mothers used SSRIs during pregnancy, Zoloft® lawsuits and Paxil® lawsuits are currently being filed in increasing number across the country. Our team of Zoloft® lawyers and Paxil® lawyers has the skill, resources, and compassion needed to secure the justice your family deserves. If you or a loved one used SSRIs during pregnancy and your child was born with a birth defect, please do not hesitate to contact us for a free, no obligation consultation at (855) 452-5529 or e-mail me personally at justinian@dangerousdrugs.us. We are here to help.

About this Blog

This blog chronicles legal and scientific news relating to personal injuries caused by defective drugs and medical devices. It is published by injury lawyer Justinian C. Lane, an attorney who takes a personal interest in each of his clients’ cases.